Septic shock
Conditions
Brief summary
There are 2 primary endpoints: i) for treatment selection at interim analysis: the percentage of patients with heart rate within the predefined threshold (80-94 bpm) at hour-48; in case of similar percentages, the percentage of time elapsed within the threshold between inclusion and hour-48 will be considered ii) for the final analysis: 28-day mortality.
Detailed description
Determine the tolerance of ivabradine, Evaluate the impact of ivabradine-driven heart rate control on systemic hemodynamics, myocardial stress, organ dysfunction, morbidity, and intensive care mortality, Determine the pharmacokinetics of ivabradine
Interventions
DRUGPlacebo of Procoralan 5 mg
DRUGProcoralan 5 mg film-coated tablets
Sponsors
Assistance Publique Hopitaux De Paris
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| There are 2 primary endpoints: i) for treatment selection at interim analysis: the percentage of patients with heart rate within the predefined threshold (80-94 bpm) at hour-48; in case of similar percentages, the percentage of time elapsed within the threshold between inclusion and hour-48 will be considered ii) for the final analysis: 28-day mortality. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determine the tolerance of ivabradine, Evaluate the impact of ivabradine-driven heart rate control on systemic hemodynamics, myocardial stress, organ dysfunction, morbidity, and intensive care mortality, Determine the pharmacokinetics of ivabradine | — |
Countries
France
Outcome results
None listed